Trial Outcomes & Findings for Lung-MAP: Durvalumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers (NCT NCT02766335)

NCT ID: NCT02766335

Last Updated: 2023-05-25

Results Overview

The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 116 participants
• Primary outcome timeframe: Up to 3 years post registration
• Results posted on: 2023-05-25

Participant Flow

Arm 1: 78 participants randomized to the durvalumab arm, 9 ineligible and 1 did not receive any treatment. Thus 68 were eligible and evaluable for analyses. 4 participants were re-registered after progression to receive additional treatment with MEDI4736 Arm 2: 38 participants randomized to the docetaxel arm, 30 were eligible and evaluable for analyses due to 2 being ineligible and 6 not receiving any protocol treatment.

Participant milestones

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm III - MEDI4736 Retreatment For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Initial Registration STARTED	68	30	0
Initial Registration Eligible Participants Enrolled Before Docetaxel Arm Closed	32	30	0
Initial Registration COMPLETED	10	0	0
Initial Registration NOT COMPLETED	58	30	0
Re-registration of Arm I to MEDI4738 STARTED	0	0	4
Re-registration of Arm I to MEDI4738 COMPLETED	0	0	2
Re-registration of Arm I to MEDI4738 NOT COMPLETED	0	0	2

Reasons for withdrawal

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm III - MEDI4736 Retreatment For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies
Initial Registration Adverse Event	6	3	0
Initial Registration Refusal unrelated to adverse event	1	0	0
Initial Registration Progression/relapse	49	15	0
Initial Registration Death	1	3	0
Initial Registration not protocol specified	1	9	0
Re-registration of Arm I to MEDI4738 Death	0	0	1
Re-registration of Arm I to MEDI4738 Progression/relapse	0	0	1

Baseline Characteristics

While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.

Baseline characteristics by cohort

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=68 Participants Participants receive durvalumab IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 Participants Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies	Total n=98 Participants Total of all reporting groups
Age, Continuous	66 years n=68 Participants	71 years n=30 Participants	67.3 years n=98 Participants
Age, Customized >=65 years	36 Participants n=68 Participants	21 Participants n=30 Participants	57 Participants n=98 Participants
Age, Customized <65 years	32 Participants n=68 Participants	9 Participants n=30 Participants	41 Participants n=98 Participants
Sex: Female, Male Female	27 Participants n=68 Participants	10 Participants n=30 Participants	37 Participants n=98 Participants
Sex: Female, Male Male	41 Participants n=68 Participants	20 Participants n=30 Participants	61 Participants n=98 Participants
Race/Ethnicity, Customized White	55 Participants n=68 Participants	27 Participants n=30 Participants	82 Participants n=98 Participants
Race/Ethnicity, Customized Black	6 Participants n=68 Participants	1 Participants n=30 Participants	7 Participants n=98 Participants
Race/Ethnicity, Customized Asian	5 Participants n=68 Participants	1 Participants n=30 Participants	6 Participants n=98 Participants
Race/Ethnicity, Customized Multi-racial	0 Participants n=68 Participants	1 Participants n=30 Participants	1 Participants n=98 Participants
Race/Ethnicity, Customized Unknown race	2 Participants n=68 Participants	0 Participants n=30 Participants	2 Participants n=98 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=68 Participants	0 Participants n=30 Participants	2 Participants n=98 Participants
Number of lines of prior therapy for stage IV disease 0	16 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.	—	16 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.
Number of lines of prior therapy for stage IV disease 1	39 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.	—	39 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.
Number of lines of prior therapy for stage IV disease 2	11 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.	—	11 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.
Number of lines of prior therapy for stage IV disease 3+	2 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.	—	2 Participants n=68 Participants • While the docetaxel arm was enrolling, the eligibility stated that patients must have received exactly 1 line of prior therapy for stage IV disease or platinum-based chemotherapy for stage I-III disease with progression within a year of completing therapy. Therefore, the number of lines of prior therapy for stage IV disease was not captured prior to the revision in May 2015 that closed the docetaxel arm to accrual.
Zubrod performance status 0	18 Participants n=68 Participants	10 Participants n=30 Participants	28 Participants n=98 Participants
Zubrod performance status 1	42 Participants n=68 Participants	16 Participants n=30 Participants	58 Participants n=98 Participants
Zubrod performance status 2	8 Participants n=68 Participants	4 Participants n=30 Participants	12 Participants n=98 Participants
Weight loss in past 6 months <5%	48 Participants n=68 Participants	29 Participants n=30 Participants	77 Participants n=98 Participants
Weight loss in past 6 months 5%-10%	12 Participants n=68 Participants	1 Participants n=30 Participants	13 Participants n=98 Participants
Weight loss in past 6 months 10%-<20%	6 Participants n=68 Participants	0 Participants n=30 Participants	6 Participants n=98 Participants
Weight loss in past 6 months >=20%	2 Participants n=68 Participants	0 Participants n=30 Participants	2 Participants n=98 Participants
Smoking status Current smoker	17 Participants n=68 Participants	6 Participants n=30 Participants	23 Participants n=98 Participants
Smoking status Former smoker	47 Participants n=68 Participants	21 Participants n=30 Participants	68 Participants n=98 Participants
Smoking status Never smoker	4 Participants n=68 Participants	3 Participants n=30 Participants	7 Participants n=98 Participants
Brain metatases reported at baseline Yes	4 Participants n=68 Participants	1 Participants n=30 Participants	5 Participants n=98 Participants
Brain metatases reported at baseline No	64 Participants n=68 Participants	29 Participants n=30 Participants	93 Participants n=98 Participants
Programmed death-ligand 1 (PD-L1) >= 25 (positive)	14 Participants n=43 Participants • PD-L1 testing was done for 43 participants on the durvalumab arm who had evaluable tissue samples. PD-L1 testing was not performed for participants on the docetaxel arm.	—	14 Participants n=43 Participants • PD-L1 testing was done for 43 participants on the durvalumab arm who had evaluable tissue samples. PD-L1 testing was not performed for participants on the docetaxel arm.
Programmed death-ligand 1 (PD-L1) < 25 (negative)	29 Participants n=43 Participants • PD-L1 testing was done for 43 participants on the durvalumab arm who had evaluable tissue samples. PD-L1 testing was not performed for participants on the docetaxel arm.	—	29 Participants n=43 Participants • PD-L1 testing was done for 43 participants on the durvalumab arm who had evaluable tissue samples. PD-L1 testing was not performed for participants on the docetaxel arm.

PRIMARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible and evaluable participants

The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=68 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Response Rate in MEDI4736-treated Participants	16 percentage of participants Interval 7.0 to 25.0	—

PRIMARY outcome

Timeframe: Up to 3 years post registration

Population: PD-L1 positive participants treated with MEDI4736

The percentage of PD-L1 positive participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=14 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Response Rate Among PD-L1 Positive Participants Treated With MEDI4736	14 percentage of participants Interval 0.0 to 33.0	—

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible and evaluable participants

Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions or an absolute increase of >= 0.5cm, or a measurable increase in a non-target lesion, or the appearance of new lesions or death due to disease without prior documentation of progression or symptomatic deterioration.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=68 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Investigator-assessed Progression-free Survival in Participants Treated With MEDI4736	2.9 months Interval 2.0 to 4.0	—

SECONDARY outcome

Timeframe: up to 3 years post registration

Population: Eligible and evaluable PD-L1 positive participants

Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause.

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions or an absolute increase of >= 0.5cm, or a measurable increase in a non-target lesion, or the appearance of new lesions or death due to disease without prior documentation of progression or symptomatic deterioration.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=14 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Investigator-assessed Progression-free Survival in PD-L1 Positive Participants Treated With MEDI4736	2.3 months Interval 1.4 to 4.2	—

SECONDARY outcome

Timeframe: Up to 3 years post-registration

Population: Eligible and evaluable participants

Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=68 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Survival in MEDI4736-treated Participants	11.6 months Interval 10.2 to 14.3	—

SECONDARY outcome

Timeframe: up to 3 years post registration

Population: Eligible and evaluable PD-L1 positive participants

Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=14 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Survival in PD-L1 Positive MEDI4736-treated Participants	10.7 months Interval 9.2 to 14.3	—

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 3 years post registration

Population: Participants who received at least one dose of protocol treatment.

Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=68 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 Participants Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Abdominal pain	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alanine aminotransferase increased	2 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anemia	4 Participants	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspartate aminotransferase increased	2 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bone pain	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bronchopulmonary hemorrhage	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea	6 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ejection fraction decreased	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue	3 Participants	5 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	0 Participants	3 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Gastrointestinal disorders - Other, specify	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Generalized muscle weakness	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypercalcemia	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyperglycemia	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hyponatremia	3 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoxia	2 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Immune system disorders - Other, specify	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infusion related reaction	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Leukocytosis	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lung infection	1 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphocyte count decreased	3 Participants	7 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis oral	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophil count decreased	0 Participants	10 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pneumonitis	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Resp, thoracic and mediastinal disorders - Other	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sepsis	0 Participants	2 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Stevens-Johnson syndrome	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Syncope	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Thromboembolic event	0 Participants	1 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Urinary tract infection	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Weight loss	1 Participants	0 Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs White blood cell decreased	0 Participants	6 Participants

SECONDARY outcome

Timeframe: up to 3 years post registration

Population: No data collected for this outcome measure

Duration from date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years post registration

Population: No data collected for this outcome measure

Duration from date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible and evaluable participants enrolled before docetaxel arm closed

Duration from date of sub-study registration (or date of screening/pre-screening registration if participant never enrolls in a sub-study) to date of death due to any cause.

Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=32 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 Participants Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Overall Survival	12.1 months Interval 9.2 to 17.7	7.7 months Interval 6.6 to 10.7

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible and evaluable participants enrolled before docetaxel arm closed

Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause.

Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=32 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 Participants Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Investigator-assessed Progression-free Survival	3.1 months Interval 2.3 to 6.4	2.8 months Interval 1.4 to 4.6

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Data were not collected for this measure

Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years post registration

Population: Eligible and evaluable participants enrolled before docetaxel arm closed

The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 or docetaxel per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.

Outcome measures

Measure	Arm I (MEDI4736 - Closed to Accrual 12/2015) n=32 Participants Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 Participants Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Response Rate	18.8 percentage of participants Interval 5.2 to 32.3	6.7 percentage of participants Interval 0.0 to 15.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will be monitored by the percentage of screened patients that register to a therapeutic sub-study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will be monitored by the percentage of patients that receive at least one dose of the treatment they are randomized to. (Design #1)

Outcome measures

Outcome data not reported

Adverse Events

Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)

Serious events: 27 serious events

Other events: 66 other events

Deaths: 58 deaths

Arm II (Docetaxel - Closed to Accrual 4/2015)

Serious events: 3 serious events

Other events: 30 other events

Deaths: 26 deaths

Serious adverse events

Measure	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736) n=68 participants at risk Arm I- Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Arm III-For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Arm III Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 participants at risk Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
General disorders Infusion related reaction	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Blood and lymphatic system disorders Anemia	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Atrial fibrillation	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Cardiac arrest	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Heart failure	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Palpitations	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Sinus tachycardia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Abdominal pain	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Diarrhea	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastric hemorrhage	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastritis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastrointestinal disorders-Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Nausea	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Vomiting	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Non-cardiac chest pain	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Hepatobiliary disorders Cholecystitis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Infections and infestations-Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Lung infection	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Sepsis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Urinary tract infection	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Injury, poisoning and procedural complications Fracture	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Alanine aminotransferase increased	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Aspartate aminotransferase increased	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Ejection fraction decreased	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypercalcemia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hyperglycemia	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypokalemia	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hyponatremia	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Pain in extremity	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified - Other	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Syncope	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Acute kidney injury	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Hypotension	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Thromboembolic event	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.

Other adverse events

Measure	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736) n=68 participants at risk Arm I- Participants receive MEDI4736 (durvalumab) IV over 60 minutes on day 1. Treatment repeats every 14 days for 12 months in the absence of disease progression or unacceptable toxicity. Arm III-For participants assigned to Arm 1, MEDI4736: Upon evidence of progression following discontinuation of 12 months of treatment, participants may restart treatment with Arm 3, MEDI4736 for up to 12 months with the same treatment guidelines followed during the initial 12-month treatment period. Participants will only be able to restart treatment once; thus a maximum of two 12-month periods will be allowed. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Arm III Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm II (Docetaxel - Closed to Accrual 4/2015) n=30 participants at risk Participants receive docetaxel IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. (closed to accrual with Revision #2 4/22/15) Docetaxel: Given IV Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	32.4% 22/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	63.3% 19/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Blood and lymphatic system disorders Leukocytosis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Atrial fibrillation	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Cardiac disorders-Other	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Chest pain - cardiac	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Heart failure	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Palpitations	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Pericardial effusion	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Sinus tachycardia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Cardiac disorders Supraventricular tachycardia	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Endocrine disorders Endocrine disorders-Other	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Endocrine disorders Hyperparathyroidism	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Endocrine disorders Hyperthyroidism	13.2% 9/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Endocrine disorders Hypothyroidism	13.2% 9/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Eye disorders Blurred vision	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Eye disorders Dry eye	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Eye disorders Eye disorders-Other	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Eye disorders Eye pain	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Eye disorders Flashing lights	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Eye disorders Watering eyes	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Abdominal pain	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Anal pain	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Bloating	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Colitis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Constipation	27.9% 19/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	33.3% 10/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Dental caries	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Diarrhea	19.1% 13/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	30.0% 9/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Dry mouth	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Dyspepsia	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Dysphagia	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Enterocolitis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastritis	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastroesophageal reflux disease	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastrointestinal disorders-Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Gastrointestinal pain	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Mucositis oral	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	20.0% 6/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Nausea	32.4% 22/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	36.7% 11/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Gastrointestinal disorders Vomiting	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	20.0% 6/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Chills	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Death NOS	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Edema face	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Edema limbs	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Fatigue	48.5% 33/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	70.0% 21/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Fever	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Flu like symptoms	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Gait disturbance	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders General disorders and admin site conditions - Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Infusion related reaction	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Injection site reaction	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Malaise	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Non-cardiac chest pain	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
General disorders Pain	16.2% 11/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Immune system disorders Immune system disorders-Other	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Bronchial infection	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Enterocolitis infectious	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Infections and infestations-Other	7.4% 5/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Lung infection	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Mucosal infection	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Nail infection	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Papulopustular rash	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Sepsis	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Sinusitis	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Skin infection	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Soft tissue infection	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Upper respiratory infection	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Infections and infestations Urinary tract infection	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Injury, poisoning and procedural complications Bruising	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Injury, poisoning and procedural complications Fall	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Injury, poisoning and procedural complications Fracture	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Injury, poisoning and procedural complications Spinal fracture	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Injury, poisoning and procedural complications Wound complication	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Activated partial thromboplastin time prolonged	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Alanine aminotransferase increased	17.6% 12/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Alkaline phosphatase increased	26.5% 18/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Aspartate aminotransferase increased	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Blood bilirubin increased	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Cardiac troponin I increased	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Cholesterol high	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Creatinine increased	16.2% 11/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Ejection fraction decreased	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Electrocardiogram QT corrected interval prolonged	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations INR increased	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Investigations-Other	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Lipase increased	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Lymphocyte count decreased	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	43.3% 13/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Neutrophil count decreased	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	33.3% 10/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Platelet count decreased	7.4% 5/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Serum amylase increased	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Urine output decreased	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Weight gain	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations Weight loss	25.0% 17/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Investigations White blood cell decreased	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	36.7% 11/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Alcohol intolerance	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Anorexia	29.4% 20/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	43.3% 13/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Dehydration	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypercalcemia	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hyperglycemia	20.6% 14/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hyperkalemia	11.8% 8/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypermagnesemia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypertriglyceridemia	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypoalbuminemia	23.5% 16/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	36.7% 11/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypocalcemia	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypoglycemia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypokalemia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypomagnesemia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hyponatremia	30.9% 21/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	26.7% 8/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Hypophosphatemia	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Arthralgia	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Back pain	20.6% 14/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Bone pain	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Chest wall pain	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Flank pain	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	23.3% 7/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tiss disorder - Other	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	20.0% 6/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Musculoskeletal and connective tissue disorders Pain in extremity	16.2% 11/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Ataxia	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Concentration impairment	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Depressed level of consciousness	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Dizziness	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	20.0% 6/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Dysgeusia	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	16.7% 5/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Encephalopathy	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Headache	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Lethargy	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Memory impairment	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Paresthesia	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Peripheral motor neuropathy	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Peripheral sensory neuropathy	7.4% 5/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	20.0% 6/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Presyncope	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Somnolence	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Syncope	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Nervous system disorders Tremor	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Psychiatric disorders Agitation	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Psychiatric disorders Anxiety	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Psychiatric disorders Confusion	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Psychiatric disorders Depression	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Psychiatric disorders Insomnia	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	13.3% 4/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Acute kidney injury	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Chronic kidney disease	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Hematuria	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Proteinuria	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Renal and urinary disorders-Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Urinary frequency	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Urinary incontinence	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Urinary retention	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Renal and urinary disorders Urinary urgency	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Reproductive system and breast disorders Vaginal inflammation	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Aspiration	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Cough	27.9% 19/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	23.3% 7/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Dyspnea	27.9% 19/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	40.0% 12/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Hoarseness	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pharyngeal hemorrhage	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Postnasal drip	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Productive cough	7.4% 5/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Resp, thoracic and mediastinal disorders - Other	8.8% 6/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Sore throat	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Respiratory, thoracic and mediastinal disorders Wheezing	7.4% 5/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Alopecia	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	30.0% 9/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Dry skin	7.4% 5/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Erythema multiforme	2.9% 2/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.4% 3/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Nail discoloration	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	10.0% 3/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Nail loss	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Nail ridging	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Pruritus	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Rash acneiform	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Rash maculo-papular	14.7% 10/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	5.9% 4/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Skin and subcutaneous tissue disorders Urticaria	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Surgical and medical procedures Surgical and medical procedures-Other	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Hot flashes	1.5% 1/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	0.00% 0/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Hypertension	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	6.7% 2/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Hypotension	10.3% 7/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	20.0% 6/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Phlebitis	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Superior vena cava syndrome	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Thromboembolic event	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.
Vascular disorders Vascular disorders-Other	0.00% 0/68 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.	3.3% 1/30 • Duration of treatment and follow up until death or 3 years post registration Only 98 participants were assessed for AEs, as 9 participants on the MEDI4736 arm and 2 on the docetaxel arm were ineligible. In addition, 1 participant on the MEDI4736 arm and 6 participants on the docetaxel arm did not receive any protocol therapy, so were not evaluable for adverse events. It was pre-specified in the Study Protocol to pool the AE data from Arm I and Arm III for the purposes of Adverse Events reporting for participants who received MEDI4736.

Additional Information

Lung Committee Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: kmini@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60