Non Serious Adverse Drug Reactions Report |
Start Date:2016-05-18 End Date:2016-05-19 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-0059 | Subject Initials :LKH | DOB :08/05/1981 | Sex:Female | Race:Asian | Height:153cm | Weight:74g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 06/02/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 06/13/2015 | 07/02/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | None | 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:2016-05-18 End Date:2016-05-19 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-036 | Subject Initials :JSY | DOB :07/28/1981 | Sex:Female | Race:Asian | Height:162cm | Weight:54g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 03/13/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 03/24/2015 | 04/07/2015 | | Related | Moderate |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | None | 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:2016-05-18 End Date:2016-05-19 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-040 | Subject Initials :LBH | DOB :03/05/1985 | Sex:Female | Race:Asian | Height:164cm | Weight:61g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 04/06/2015 | 225 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 04/15/2015 | 04/30/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | None | 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:2016-05-18 End Date:2016-05-19 |
Study :EMR700623-541 | Investigator :NA | Country of Investigator :Korea | SiteNo:K01 |
Subject No :k01-050 | Subject Initials :KHG | DOB :04/22/1984 | Sex:Female | Race:Asian | Height:150cm | Weight:46g |
First administration date of batch : | Batch number : |
Study Drug | Start Date | Dose | Change in Dose |
Gonal-f New Pen Stimulation Treatment | 05/03/2015 | 300 | |
Adverse Event | Start Date | End Date | Time related to study treatment | Causality to study drug | Severity |
OHSS | 05/14/2015 | 05/29/2015 | | Related | Mild |
Causality Factors | Action Taken with Study Treatment | Other action taken | Outcome | AE Special Interest | AE dose limiting toxicity |
None(Othervalue:) | Dose not changed | 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 |
ovary cystectomy | UK-Jan-2014 | Not on treatment/medication | |