Adverse Event Form
Participant ID: ____ P. I. name: Dr. Priya Gopalan PhD, MD Site ID: ___
Name of the Protocol: An open-label, multicenter phase II study to compare the efficacy of carboplatin as first-line followed by second-line olaparib versus olaparib as firstline followed by second-line carboplatin in the treatment of patients with castration resistant prostate cancer containing homologous recombination deficiency
Protocol ID: COBRA
Severity
1 = Mild
2 = Moderate
3 = Severe
4 = LifeThreatening
5 = Death
Relation to
Investigational
Drug
0 = definitely Not
related
1 = Possibly
related
2 = Probably
related
3 = Definitely
related
Action Taken
with Investigational
Drug
0 = None
1= Injection
Interrupted
Treatment Required
Outcome of AE
1 = Recovered
2 = Recovered with sequelae
3 = Recovering
4 = Not Recovered
5 = Fatal
1= Yes
2= No
Serious Adverse
Event (SAE)
1 = Yes
2 = No
(If yes, complete SAE form)
At end of the study only: Check the box if the participant had no adverse events ☐
Adverse Event
Start Date
Stop Date
Signature of the person performing the documentation
Signature and the Principal Investigator
Version 1.1 C/S 06/09/2021
Severity
Relatio
nship
Action
Taken
Treatment required
Outcome of AE
SAE?
Adverse Event Form
Participant ID: ____ P. I. name: Dr. Priya Gopalan PhD, MD Site ID: ___
Name of the Protocol: An open-label, multicenter phase II study to compare the efficacy of carboplatin as first-line followed by second-line olaparib versus olaparib as firstline followed by second-line carboplatin in the treatment of patients with castration resistant prostate cancer containing homologous recombination deficiency
Protocol ID: COBRA
Version 1.1 C/S 06/09/2021