Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0095 | Subject Initials :MLG | DOB :08/19/1990 | Sex:Female | Race:Asian | Height:155cm | Weight:54.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/19/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/31/2015 | 06/05/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0102 | Subject Initials :HYD | DOB :10/14/1985 | Sex:Female | Race:Asian | Height:163cm | Weight:57.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/19/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/01/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Palace laparoscopy | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0103 | Subject Initials :CPZ | DOB :05/12/1989 | Sex:Female | Race:Asian | Height:165cm | Weight:63.5kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/19/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/02/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
The right side of the open line on the right side of salpingectomy tubal pregnancy | Uk-Unk-2011 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0111 | Subject Initials :CXW | DOB :10/10/1979 | Sex:Female | Race:Asian | Height:162cm | Weight:68.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/20/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/02/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Ectopic pregnancy laparoscopic surgery, the left fallopian tube embryo window. | Uk-Unk-2012 | Not on treatment/medication | |
Tubal lipiodol angiography | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0115 | Subject Initials :KJT | DOB :07/02/1988 | Sex:Female | Race:Asian | Height:163cm | Weight:52.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/06/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG examination: bilateral tubal occlusion | Uk-Unk-2012 | Not on treatment/medication | |
Laparoscopy surgery: pelvic sticky points, bilateral tubal ostomy + right side mesosalpinx cyst removal. | Uk-May-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0118 | Subject Initials :MLF | DOB :08/03/1984 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction | Uk-Unk-2007 | Not on treatment/medication | |
Laparoscopic pelvic sticky points, bilateral ovarian drilling | Uk-Unk-2007 | Not on treatment/medication | |
Cervical biopsy showing inflammation | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0124 | Subject Initials :Y-C | DOB :07/17/1982 | Sex:Female | Race:Asian | Height:150cm | Weight:48.5kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: the left fallopian tube obstruction and hydrocephalus right salpingitis | Uk-Unk-2013 | Not on treatment/medication | |
Hysteroscopy normal | Uk-Mar-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0126 | Subject Initials :RCM | DOB :01/09/1989 | Sex:Female | Race:Asian | Height:165cm | Weight:60.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/21/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: the right fallopian tube obstruction, poor uterine shape | Uk-Unk-2013 | Not on treatment/medication | |
Hysteroscopy: uterine spindle-shaped, single horn. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0134 | Subject Initials :QYL | DOB :06/17/1986 | Sex:Female | Race:Asian | Height:155cm | Weight:47.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/06/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Laparotomy: pelvic abscess incision and drainage, the right accessories cystectomy | Uk-Unk-2009 | Not on treatment/medication | |
Hysteroscopy normal uterine shape | Uk-Unk-2013 | Not on treatment/medication | |
Hysteroscopic curettage | Uk-Unk-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0136 | Subject Initials :Q-L | DOB :03/28/1984 | Sex:Female | Race:Asian | Height:154cm | Weight:47.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/08/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction incomplete | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0137 | Subject Initials :YLF | DOB :11/01/1989 | Sex:Female | Race:Asian | Height:153cm | Weight:47.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/09/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0138 | Subject Initials :TTJ | DOB :06/20/1990 | Sex:Female | Race:Asian | Height:150cm | Weight:41.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/06/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Ectopic pregnancy laparoscopic surgery: the right fallopian tube embryo pelvic sticking points | Uk-Jan-2014 | Not on treatment/medication | |
Hysteroscopy: endometrial polyps. | Uk-Feb-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0142 | Subject Initials :HMT | DOB :02/19/1988 | Sex:Female | Race:Asian | Height:168cm | Weight:46.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/07/2015 | 06/12/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Other(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction and hydrocephalus | Uk-Unk-2014 | Not on treatment/medication | |
Laparoscopy surgery: pelvic stars stick + fulguration of endometriosis foci, tubal plastic surgery | Uk-Unk-2014 | Not on treatment/medication | |
|
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0143 | Subject Initials :F-L | DOB :11/06/1982 | Sex:Female | Race:Asian | Height:155cm | Weight:51.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/22/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/08/2015 | 06/14/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: the left fallopian tube obstruction, incomplete right fallopian tube obstruction | Uk-Unk-2012 | Not on treatment/medication | |
Laparoscopy surgery: pelvic stars stick + tubal surgery, endometriosis lesions fulguration | Uk-Unk-2012 | Not on treatment/medication | |
|
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0153 | Subject Initials :H-H | DOB :07/12/1979 | Sex:Female | Race:Asian | Height:153cm | Weight:43.5kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/25/2015 | 250 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
|
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0157 | Subject Initials :Y-Z | DOB :07/22/1984 | Sex:Female | Race:Asian | Height:156cm | Weight:55.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/25/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction | Uk-Unk-2010 | Not on treatment/medication | |
Laparoscopic Surgery: Tubal clear. | Uk-Unk-2007 | Not on treatment/medication | |
Ectopic pregnancy laparoscopic surgery: tubal embryo window. | Uk-Jan-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0161 | Subject Initials :H-Y | DOB :12/12/1985 | Sex:Female | Race:Asian | Height:166cm | Weight:57.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/26/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction | Uk-Unk-2007 | Not on treatment/medication | |
Laparoscopic tubal surgery sticking points. | Uk-Unk-2007 | Not on treatment/medication | |
Open left fallopian tube ectopic pregnancy surgery | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0164 | Subject Initials :AHC | DOB :12/12/1982 | Sex:Female | Race:Asian | Height:156cm | Weight:49.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/26/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/12/2015 | 06/20/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal occlusion side | Uk-Unk-2012 | Not on treatment/medication | |
Laparoscopy Surgery: salpingostomy, pelvic adhesions dissection. | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0169 | Subject Initials :L-W | DOB :06/08/1985 | Sex:Female | Race:Asian | Height:166cm | Weight:50.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/12/2015 | 06/20/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | None | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal occlusion insufficiency | Uk-Jun-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0174 | Subject Initials :YXC | DOB :06/04/2015 | Sex:Female | Race:Asian | Height:155cm | Weight:54.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/12/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Laparoscopic surgery: left ovarian endometriosis cystectomy | Uk-Unk-2010 | Not on treatment/medication | |
HSG: the left fallopian tube obstruction, right fallopian tube inflammation. | Uk-Unk-2012 | Not on treatment/medication | |
Laparoscopic surgery: pelvic adhesions dissection, left fallopian tube plastic surgery | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0175 | Subject Initials :L-T | DOB :02/15/1989 | Sex:Female | Race:Asian | Height:158cm | Weight:40.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/11/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal obstruction. | Uk-Aug-2014 | Not on treatment/medication | |
Laparoscopy surgery: pelvic adhesions dissection, tubal plastic surgery to repair the left corpus luteum cyst cystectomy, | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0176 | Subject Initials :KBF | DOB :05/19/1986 | Sex:Female | Race:Asian | Height:160cm | Weight:57.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/11/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Tubal examination: passable | Uk-Unk-2008 | Not on treatment/medication | |
HSG: bilateral tubal occlusion | Uk-Unk-2009 | Not on treatment/medication | |
Laparoscopy surgery: bilateral tubal repair plastic surgery, pelvic adhesions dissection | Uk-Unk-2011 | Not on treatment/medication | |
Ectopic pregnancy: open surgery | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0178 | Subject Initials :XSC | DOB :10/11/1988 | Sex:Female | Race:Asian | Height:155cm | Weight:54.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/10/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal resistance. | Uk-Jan-2013 | Not on treatment/medication | |
Laparoscopy surgery: pelvic adhesions dissection, bilateral salpingo-repair plastic surgery, normal uterine shape. | Uk-Jan-2013 | Not on treatment/medication | |
Hysteroscopy normal, water surgery: incomplete right fallopian tube obstruction | Uk-Feb-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0179 | Subject Initials :HYZ | DOB :05/14/1991 | Sex:Female | Race:Asian | Height:158cm | Weight:53.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/11/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Ectopic pregnancy laparotomy: the left fallopian tube removal. | Uk-Unk-2009 | Not on treatment/medication | |
Abdominal ectopic pregnancy conservative surgery. | Uk-Unk-2010 | Not on treatment/medication | |
Hysteroscopy: endometrial polyp excision. | Uk-Jan-2015 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0180 | Subject Initials :YPW | DOB :08/20/1982 | Sex:Female | Race:Asian | Height:156cm | Weight:57.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/27/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/13/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Ectopic pregnancy: treatment of chemical drugs to kill embryos | Uk-Unk-2012 | Not on treatment/medication | |
HSG: bilateral tubal occlusion | Uk-Unk-2008 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0185 | Subject Initials :YMX | DOB :09/07/1975 | Sex:Female | Race:Asian | Height:159cm | Weight:63.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/15/2015 | 06/20/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal occlusion | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0190 | Subject Initials :F-H | DOB :03/09/1984 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/12/2015 | 06/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:No |
Condition | Start Date | Related to study condition | Ongoing |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0191 | Subject Initials :SYZ | DOB :02/16/1983 | Sex:Female | Race:Asian | Height:162cm | Weight:58.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 200 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/14/2015 | 06/18/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal occlusion with effusion | Uk-Unk-2008 | Not on treatment/medication | |
Tubal treatment: Tips patency | Uk-Unk-2008 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0195 | Subject Initials :J-L | DOB :08/15/1984 | Sex:Female | Race:Asian | Height:156cm | Weight:48.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/14/2015 | 06/18/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal patency, pelvic adhesions. | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0200 | Subject Initials :L-Z | DOB :12/17/1988 | Sex:Female | Race:Asian | Height:155cm | Weight:70.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/28/2015 | 187.5 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/13/2015 | 06/18/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral obstruction | Uk-Apr-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0202 | Subject Initials :F-Q | DOB :06/09/1985 | Sex:Female | Race:Asian | Height:159cm | Weight:65.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/27/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/11/2015 | 09/16/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal patency | Uk-Unk-2013 | Not on treatment/medication | |
Laparoscopic surgery: pelvic adhesions dissection, bilateral mesosalpinx cystectomy | Uk-Unk-2014 | Not on treatment/medication | |
Tubal examination: smooth | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0206 | Subject Initials :YPZ | DOB :10/20/1980 | Sex:Female | Race:Asian | Height:150cm | Weight:47.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 187.5 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/14/2015 | 09/18/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
HSG: bilateral tubal occlusion | Uk-Unk-2011 | Not on treatment/medication | |
Laparoscopy surgery: pelvic adhesions dissection, bilateral tubal surgery to clear. | Uk-Unk-2011 | Not on treatment/medication | |
HSG: bilateral tubal occlusion | Uk-Unk-2013 | Not on treatment/medication | |
Laparoscopy surgery: pelvic adhesions dissection, uterine fibroids dug surgery, tubal surgery to clear, coherent liquid skill. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0207 | Subject Initials :JHZ | DOB :09/03/2015 | Sex:Female | Race:Asian | Height:160cm | Weight:55.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/13/2015 | 09/18/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS patients, improved canceled after embryo transfer. |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Ectopic pregnancy laparoscopic surgery: Left salpingectomy | Uk-Unk-2011 | Not on treatment/medication | |
Ectopic pregnancy laparoscopic surgery: Right salpingectomy | Uk-Unk-2013 | Not on treatment/medication | |
HSG: bilateral tubal occlusion | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-04-26 End Date:2016-04-27 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0208 | Subject Initials :MQW | DOB :09/24/1988 | Sex:Female | Race:Asian | Height:156cm | Weight:54.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/28/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/14/2015 | 09/18/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Not applicable | Led to study termination | Resolved | | |
Event Description:Moderate OHSS occurs canceled embryo transfer, OHSS improvement |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Hysteroscopic resection of endometrial polyps | Uk-Unk-2015 | Not on treatment/medication | |