Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0043 | Subject Initials :F-H | DOB :03/13/1983 | Sex:Female | Race:Asian | Height:164cm | Weight:54.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/13/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/30/2015 | 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: |
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 tubal ectopic pregnancy at the right side of the window to take embryo | Uk-Unk-2005 | Not on treatment/medication | |
Under the right fallopian tube ectopic pregnancy laparoscopic surgery | Uk-Unk-2007 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0046 | Subject Initials :Q-H | DOB :10/07/1985 | Sex:Female | Race:Asian | Height:161cm | Weight:50.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/13/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/28/2015 | 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: |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0049 | Subject Initials :HPT | DOB :09/16/1980 | Sex:Female | Race:Asian | Height:155cm | Weight:50.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 187.5 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/31/2015 | 06/03/2015 | | 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: |
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 appendicitis | Uk-Unk-2012 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0052 | Subject Initials :YLL | DOB :02/07/1992 | Sex:Female | Race:Asian | Height:165cm | Weight:54.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/30/2015 | 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: |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0053 | Subject Initials :YND | DOB :04/13/1992 | Sex:Female | Race:Asian | Height:155cm | Weight:45.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/30/2015 | 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: |
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 tubal colostomy, pelvic surgery sticky points. | Uk-Unk-2013 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0059 | Subject Initials :J-L | DOB :12/23/1984 | Sex:Female | Race:Asian | Height:155cm | Weight:50.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 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: |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0062 | Subject Initials :FQR | DOB :07/25/1983 | Sex:Female | Race:Asian | Height:162cm | Weight:46.0kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/14/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/30/2015 | 06/03/2015 | | 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: |
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 tubal inspection | Uk-May-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :China | SiteNo:C02 |
Subject No :C02-0071 | Subject Initials :LLX | DOB :07/13/1987 | Sex:Female | Race:Asian | Height:157cm | Weight:41.5kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/15/2015 | 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: |
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 pelvic sub sticky, sticky points left fallopian tube surgery. | Uk-Unk-2014 | Not on treatment/medication | |
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
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: |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0010 | Subject Initials :Q-Z | DOB :01/31/1990 | Sex:Female | Race:Asian | Height:159cm | Weight:45kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/02/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/17/2015 | 08/24/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;nausea Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0013 | Subject Initials :L-L | DOB :06/12/1986 | Sex:Female | Race:Asian | Height:159cm | Weight:54.5kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/02/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/18/2015 | 08/20/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Disease under study**,Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;nausea ,ascites,Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 18-Aug-2015 / 20-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
ampullary pregnancy | UK-Unk-2010 | Not on treatment/medication | |
ampullary pregnancy | UK-Unk-2012 | Not on treatment/medication | |
ampullary pregnancy | UK-Unk-2013 | Not on treatment/medication | |
salpingocatheterism | UK-Unk-2013 | Not on treatment/medication | |
|
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0021 | Subject Initials :FYZ | DOB :08/28/1990 | Sex:Female | Race:Asian | Height:150cm | Weight:45kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/04/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/19/2015 | 08/21/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
salpingocatheterism | UK-Unk-2012 | Not on treatment/medication | |
|
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0041 | Subject Initials :W-Y | DOB :07/03/1981 | Sex:Female | Race:Asian | Height:153cm | Weight:55kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/08/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/23/2015 | 08/25/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 21-Aug-2015 / 25-Aug-2015 |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0056 | Subject Initials :X-P | DOB :06/14/1983 | Sex:Female | Race:Asian | Height:158cm | Weight:46kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/13/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/27/2015 | 08/29/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0068 | Subject Initials :YPL | DOB :12/07/1985 | Sex:Female | Race:Asian | Height:160cm | Weight:50kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/15/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 08/27/2015 | 08/29/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Fallopian tube repair anaplasty | UK-Unk-2010 | Not on treatment/medication | |
|
Non Serious Adverse Drug Reactions Report |
Start Date:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0117 | Subject Initials :Y-L | DOB :04/16/1982 | Sex:Female | Race:Asian | Height:165cm | Weight:48kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/23/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/08/2015 | 09/10/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose reduced | Led to study termination | Resolved | | |
Event description:abdominal distention;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 19-Aug-2015 / 21-Aug-2015 |
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:2016-02-26 End Date:2016-03-14 |
Study :EMR700623-541 | Investigator :Ying Zhong | Country of Investigator :China | SiteNo:C05 |
Subject No :C05-0141 | Subject Initials :XHZ | DOB :04/14/1987 | Sex:Female | Race:Asian | Height:158cm | Weight:48kg |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 08/29/2015 | 150 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 09/12/2015 | 09/14/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
Protocol procedure**,Concomitant medication**(Othervalue:) | Dose not changed | Led to study termination | Resolved | | |
Event description:abdominal distention;nausea ;ascites;Drug:Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection 500ml,ivgtt bid calcium gluconate injection 10ml+dextrose injection 500ml ivgtt qd 17-Aug-2015 / 27-Aug-2015 |
Subject received concomitant medications: |
Does the subject have any relevant past or present medical conditions:Yes |
Condition | Start Date | Related to study condition | Ongoing |
Fallopian tube repair anaplasty | UK-Unk-2009 | Not on treatment/medication | |
|