Trial Outcomes & Findings for 131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat (NCT NCT02035137)

NCT ID: NCT02035137

Last Updated: 2022-06-08

Results Overview

To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 114 participants
• Primary outcome timeframe: 43-50 days from study day 1
• Results posted on: 2022-06-08

Participant Flow

Participant milestones

Measure	Single-Agent 131I-MIBG Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat
Overall Study STARTED	38	37	39
Overall Study COMPLETED	36	35	34
Overall Study NOT COMPLETED	2	2	5

Reasons for withdrawal

Measure	Single-Agent 131I-MIBG Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat
Overall Study Physician Decision	0	0	1
Overall Study Withdrawal by Subject	0	1	2
Overall Study Ineligible	0	1	2
Overall Study Disease progression prior to treatment start	2	0	0

Baseline Characteristics

131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat

Baseline characteristics by cohort

Measure	Single-Agent 131I-MIBG n=38 Participants Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan n=36 Participants Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat n=37 Participants Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat	Total n=111 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	34 Participants n=7 Participants	36 Participants n=5 Participants	107 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	17 Participants n=7 Participants	16 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	19 Participants n=7 Participants	21 Participants n=5 Participants	59 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	27 Participants n=7 Participants	25 Participants n=5 Participants	82 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	23 Participants n=7 Participants	23 Participants n=5 Participants	72 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment Canada	1 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment United States	37 participants n=5 Participants	35 participants n=7 Participants	36 participants n=5 Participants	108 participants n=4 Participants

PRIMARY outcome

Timeframe: 43-50 days from study day 1

Population: Number of eligible randomized patients who received 131-I-MIBG therapy

To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.

Outcome measures

Measure	Single-Agent 131I-MIBG n=36 Participants Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan n=35 Participants Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat n=34 Participants Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat
Objective Tumor Response After One Course of Therapy	5 Participants	5 Participants	11 Participants

SECONDARY outcome

Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months

Population: Patients who were eligible, randomized, and received 131I-MIBG treatment

Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG

Outcome measures

Measure	Single-Agent 131I-MIBG n=36 Participants Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan n=35 Participants Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat n=34 Participants Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat
Number of Participants With Grade 3 or Greater Non-hematologic Toxicities	7 Participants	17 Participants	12 Participants

Adverse Events

Single-Agent 131I-MIBG

Serious events: 6 serious events

Other events: 37 other events

Deaths: 11 deaths

131I-MIBG With Vincristine/Irinotecan

Serious events: 12 serious events

Other events: 35 other events

Deaths: 17 deaths

131I-MIBG With Vorinostat

Serious events: 5 serious events

Other events: 35 other events

Deaths: 18 deaths

Serious adverse events

Measure	Single-Agent 131I-MIBG n=38 participants at risk Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan n=36 participants at risk Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat n=37 participants at risk Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat
Gastrointestinal disorders 10000060-Abdominal distension	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10000081-Abdominal pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Blood and lymphatic system disorders 10002272-Anemia	10.5% 4/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	16.7% 6/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10002646-Anorexia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10003988-Back pain	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10007810-Catheter related infection	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10010774-Constipation	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10011224-Cough	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10012174-Dehydration	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10012727-Diarrhea	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10013781-Dry mouth	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10016256-Fatigue	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Blood and lymphatic system disorders 10016288-Febrile neutropenia	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10016558-Fever	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10019211-Headache	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020943-Hypoalbuminemia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020949-Hypocalcemia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021018-Hypokalemia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021038-Hyponatremia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021059-Hypophosphatemia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10021143-Hypoxia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10021328-Ileus	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders 10022437-Insomnia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10024264-Lethargy	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10025256-Lymphocyte count decreased	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10028411-Myalgia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10028813-Nausea	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10029366-Neutrophil count decreased	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10033425-Pain in extremity	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders 10034960-Photophobia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10035528-Platelet count decreased	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.9% 5/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10035598-Pleural effusion	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Cardiac disorders 10040752-Sinus tachycardia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10047700-Vomiting	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10047900-Weight loss	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10048677-Buttock pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10049182-White blood cell decreased	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.9% 5/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049737-Treatment related secondary malignancy	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10059827-Rhinitis infective	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations CLOSTRIDIUM DIFFICILE	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations ENTEROBACTER CLOCACAE	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PILONIDAL CYST	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module

Other adverse events

Measure	Single-Agent 131I-MIBG n=38 participants at risk Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG	131I-MIBG With Vincristine/Irinotecan n=36 participants at risk Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vincristine Irinotecan	131I-MIBG With Vorinostat n=37 participants at risk Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG Vorinostat
Nervous system disorders 10013573-Dizziness	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10013781-Dry mouth	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.1% 3/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders 10013786-Dry skin	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10013911-Dysgeusia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10013946-Dyspepsia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10013963-Dyspnea	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10000060-Abdominal distension	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10000081-Abdominal pain	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	30.6% 11/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10000636-Activated partial thromboplastin time prolonged	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	43.2% 16/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders 10001497-Agitation	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10001551-Alanine aminotransferase increased	55.3% 21/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	61.1% 22/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	45.9% 17/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10001675-Alkaline phosphatase increased	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.5% 5/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Immune system disorders 10001718-Allergic reaction	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10001723-Allergic rhinitis	10.5% 4/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders 10001760-Alopecia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.9% 5/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10002167-Anal pain	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Blood and lymphatic system disorders 10002272-Anemia	89.5% 34/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	91.7% 33/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	86.5% 32/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10002646-Anorexia	26.3% 10/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	41.7% 15/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	37.8% 14/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders 10002855-Anxiety	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.1% 3/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10003481-Aspartate aminotransferase increased	60.5% 23/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	58.3% 21/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	56.8% 21/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10003988-Back pain	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.1% 3/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10005364-Blood bilirubin increased	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.1% 3/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders 10005886-Blurred vision	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10006002-Bone pain	13.2% 5/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Injury, poisoning and procedural complications 10006504-Bruising	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	10.8% 4/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10007810-Catheter related infection	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10007839-CD4 lymphocytes decreased	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10008496-Chest wall pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10008531-Chills	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10009887-Colitis	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10010774-Constipation	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	30.6% 11/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	18.9% 7/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10011224-Cough	31.6% 12/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	22.2% 8/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	29.7% 11/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10011368-Creatinine increased	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	10.8% 4/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10012174-Dehydration	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	19.4% 7/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders 10012378-Depression	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10012727-Diarrhea	10.5% 4/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	66.7% 24/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	21.6% 8/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Ear and labyrinth disorders 10014020-Ear pain	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10014222-Edema face	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	19.4% 7/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10014383-Electrocardiogram QT corrected interval prolonged	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.1% 3/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10015090-Epistaxis	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders 10015958-Eye pain	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10016059-Facial pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10016256-Fatigue	28.9% 11/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	44.4% 16/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	32.4% 12/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Blood and lymphatic system disorders 10016288-Febrile neutropenia	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10016558-Fever	26.3% 10/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	27.8% 10/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	27.0% 10/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders 10016778-Floaters	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10016791-Flu like symptoms	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Vascular disorders 10016825-Flushing	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Injury, poisoning and procedural complications 10017076-Fracture	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10017577-Gait disturbance	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10019211-Headache	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	16.7% 6/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.5% 5/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Ear and labyrinth disorders 10019245-Hearing impaired	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders 10019450-Hematuria	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10020039-Hiccups	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020587-Hypercalcemia	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020639-Hyperglycemia	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.9% 5/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	27.0% 10/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020647-Hyperkalemia	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020670-Hypermagnesemia	15.8% 6/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	18.9% 7/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020680-Hypernatremia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Vascular disorders 10020772-Hypertension	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.1% 3/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020870-Hypertriglyceridemia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020943-Hypoalbuminemia	21.1% 8/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	30.6% 11/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	29.7% 11/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10020949-Hypocalcemia	21.1% 8/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	25.0% 9/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	21.6% 8/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021005-Hypoglycemia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021018-Hypokalemia	21.1% 8/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	27.8% 10/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	27.0% 10/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021028-Hypomagnesemia	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	36.1% 13/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	10.8% 4/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021038-Hyponatremia	36.8% 14/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	41.7% 15/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	35.1% 13/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10021059-Hypophosphatemia	18.4% 7/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	16.7% 6/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	21.6% 8/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Vascular disorders 10021097-Hypotension	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	10.8% 4/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Endocrine disorders 10021114-Hypothyroidism	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10021143-Hypoxia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10021328-Ileus	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10022402-INR increased	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	16.2% 6/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders 10022437-Insomnia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10022998-Irritability	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10024264-Lethargy	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10025256-Lymphocyte count decreased	71.1% 27/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	77.8% 28/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	75.7% 28/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10025258-Lymphocyte count increased	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10025482-Malaise	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10028130-Mucositis oral	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10028411-Myalgia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10028735-Nasal congestion	13.2% 5/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	16.2% 6/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10028813-Nausea	36.8% 14/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	63.9% 23/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	35.1% 13/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10028836-Neck pain	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10029366-Neutrophil count decreased	89.5% 34/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	86.1% 31/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	83.8% 31/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10030980-Oral hemorrhage	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10031009-Oral pain	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	8.3% 3/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10033371-Pain	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	22.2% 8/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	10.8% 4/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10033425-Pain in extremity	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	16.7% 6/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10033987-Paresthesia	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Reproductive system and breast disorders 10034310-Penile pain	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10034620-Peripheral sensory neuropathy	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders 10034960-Photophobia	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10035528-Platelet count decreased	92.1% 35/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	94.4% 34/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	91.9% 34/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10035598-Pleural effusion	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10036790-Productive cough	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders 10037032-Proteinuria	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders 10037087-Pruritus	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders 10037868-Rash maculo-papular	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10038064-Rectal hemorrhage	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10038072-Rectal pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10038695-Respiratory failure	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10040047-Sepsis	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Cardiac disorders 10040741-Sinus bradycardia	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Cardiac disorders 10040752-Sinus tachycardia	10.5% 4/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	19.4% 7/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.5% 5/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders 10040865-Skin hyperpigmentation	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10040872-Skin infection	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10041232-Sneezing	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Nervous system disorders 10041349-Somnolence	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders 10041367-Sore throat	10.5% 4/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	19.4% 7/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10042112-Stomach pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders 10042458-Suicidal ideation	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10044055-Toothache	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10045158-Tumor pain	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10046300-Upper respiratory infection	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	11.1% 4/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders 10046539-Urinary frequency	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders 10046555-Urinary retention	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10046571-Urinary tract infection	7.9% 3/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10047700-Vomiting	39.5% 15/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	58.3% 21/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	54.1% 20/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10047900-Weight loss	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	25.0% 9/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	13.5% 5/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10048677-Buttock pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders 10048994-Bladder spasm	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10049182-White blood cell decreased	84.2% 32/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	91.7% 33/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	81.1% 30/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10050068-Edema limbs	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10051792-Infusion related reaction	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10054482-Neck edema	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations 10056910-GGT increased	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.4% 2/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders 10061322-Optic nerve disorder	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders 10062225-Urinary tract pain	5.3% 2/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10062466-Localized edema	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders 10062501-Non-cardiac chest pain	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10062572-Generalized muscle weakness	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	5.6% 2/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations 10065764-Mucosal infection	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10065776-Muscle weakness lower limb	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders 10065780-Muscle weakness left-sided	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Ear and labyrinth disorders 10065838-Middle ear inflammation	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders 10065973-Iron overload	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders 10066874-Gastroesophageal reflux disease	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders ADJUSTMENT DISORDER	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations C DIFFICILE	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders CATHETER RELATED PAIN	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders CHEST DISCOMFORT, ""TIGHTNESS""	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations CLOSTRIDIUM DIFICILE	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders CONCERN FOR DISEASE PROGRESSION AS INDICATED BY INTERVAL INCREASE IN THE SIZE OF HER OCCIPITAL MASS	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DISEASE PROGRESSION	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders DRY CRACKED LIPS	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders DYSURIA	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations ENTEROBACTER CLOACAE	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Investigations HYPERPHOSPHATEMIA	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations INFLUENZA A	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Eye disorders INJECTED EYE	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Injury, poisoning and procedural complications INJURY TO LEFT WRIST	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders IRRITATION AROUND CATHETER	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders JAW PAIN	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders KETONURIA	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders MALNUTRITION - ANOREXIA	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations MULTIPLE BACTERIAL INFECTIONS (ENTEROBACTER, CITROBACTER, KLEBSIELLA, GPC, GVC)	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Cardiac disorders MURMUR	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Psychiatric disorders ODD/ANXIETY	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders PAIN	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY -RIGHT FOOT	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
General disorders PAIN RIGHT SIDE JAW	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders PAIN, LEG	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders PAPULOERYTHEMATOUS LESIONS - LEFT CHEEK	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Reproductive system and breast disorders PARAPHIMOSIS	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations PAROTIDITIS	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PILONIDAL CYST	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders RASH - CHEST	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Skin and subcutaneous tissue disorders RASH - UPPER CHEST AND BACK	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders RESPIRATORY DEPRESSION FROM SEDATION	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Respiratory, thoracic and mediastinal disorders RHINORRHEA	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Infections and infestations RHINOVIRUS	2.6% 1/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Musculoskeletal and connective tissue disorders RIB PAIN	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Injury, poisoning and procedural complications SCRATCH	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Gastrointestinal disorders STOMACH CRAMPING	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Endocrine disorders UNCOMPENSATED HYPOTHYROIDISM	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Renal and urinary disorders URETHRAL TRAUMA	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.7% 1/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	0.00% 0/38 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	2.8% 1/36 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module	0.00% 0/37 • All adverse events from enrollment through 30 days following end of protocol therapy, an average of 6 months The 111 patients described as participants do not include the 3 ineligible patients as provided in the initial row of the participant flow module

Additional Information

NANT Medical Director

New Advances in Neuroblastoma Therapy

Phone: 3233615687

Email: nantops@chla.usc.edu

Results disclosure agreements

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