Trial Outcomes & Findings for QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma (NCT NCT02383498)

NCT ID: NCT02383498

Last Updated: 2024-05-20

Results Overview

Difference in overall response rate among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine. Overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 in the irradiated tumor site after up to 24 months among patients with Chordoma who are treated with radiation plus vaccine vs. radiation plus placebo Complete response (CR; disappearance of all target lesions and no new lesions) or partial response (PR; \>=30% decrease in the sum of the greatest diameter).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Up to 24 months
• Results posted on: 2024-05-20

Participant Flow

Participant milestones

Measure	GI-6301 Vaccine Radiation + GI-6301 Vaccine + Actigraph GI-6301 Vaccine (Yeast- Brachyury): GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9	Placebo Radiation + GI-6301 Placebo + Actigraph GI-6301 Placebo: GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9
Overall Study STARTED	11	13
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

QUILT-3.011 Phase 2 Yeast-Brachyury Vaccine Chordoma

Baseline characteristics by cohort

Measure	Vaccine n=11 Participants Radiation + GI-6301 Vaccine + Actigraph GI-6301 Vaccine (Yeast- Brachyury): GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9	Placebo n=13 Participants Radiation + GI-6301 Placebo + Actigraph GI-6301 Placebo: GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9	Total n=24 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Subjects with Locally Advanced, Unresectable, Chordoma	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Difference in overall response rate among patients with Chordoma who are treated with radiation plus placebo vs. radiation plus vaccine.

Overall response rate (ORR) defined as complete response (CR) or partial response (PR) by RECIST 1.1 in the irradiated tumor site after up to 24 months among patients with Chordoma who are treated with radiation plus vaccine vs. radiation plus placebo

Complete response (CR; disappearance of all target lesions and no new lesions) or partial response (PR; >=30% decrease in the sum of the greatest diameter).

Outcome measures

Measure	GI-6301 Vaccine n=11 Participants Radiation + GI-6301 Vaccine + Actigraph GI-6301 Vaccine (Yeast- Brachyury): GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9	Placebo n=13 Participants Radiation + GI-6301 Placebo + Actigraph GI-6301 Placebo: GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9
Overall Response Rate	1 Participants	1 Participants

Adverse Events

GI-6301 Vaccine

Serious events: 5 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	GI-6301 Vaccine n=11 participants at risk Radiation + GI-6301 Vaccine + Actigraph GI-6301 Vaccine (Yeast- Brachyury): GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9	Placebo n=13 participants at risk Radiation + GI-6301 Placebo + Actigraph GI-6301 Placebo: GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9
Gastrointestinal disorders Vomiting	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Diarrhea	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Nausea	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Urinary tract infection	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Meningitis	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Sepsis	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Wound infection	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Hyperkalemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Hyponatremia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Stroke	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Urinary retention	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Blood and lymphatic system disorders Anemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Fatigue	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Urine output decreased	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.

Other adverse events

Measure	GI-6301 Vaccine n=11 participants at risk Radiation + GI-6301 Vaccine + Actigraph GI-6301 Vaccine (Yeast- Brachyury): GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9	Placebo n=13 participants at risk Radiation + GI-6301 Placebo + Actigraph GI-6301 Placebo: GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee. Radiotherapy: Standard of care wGT3X-BT Actigraph: wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9
Investigations Lymphocyte count decreased	81.8% 9/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	84.6% 11/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations White blood cell decreased	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	38.5% 5/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Alanine aminotransferase increased	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	38.5% 5/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Aspartate aminotransferase increased	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Creatinine increased	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Weight loss	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Alkaline phosphatase increased	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Platelet count decreased	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Weight gain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Neutrophil count decreased	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Investigations Urine output decreased	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Injection site reaction	90.9% 10/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	46.2% 6/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Fatigue	54.5% 6/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	61.5% 8/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Pain	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	46.2% 6/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Flu like symptoms	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	30.8% 4/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Edema limbs	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Gait disturbance	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Malaise	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Fever	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Chills	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
General disorders Neck edema	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Nausea	54.5% 6/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	53.8% 7/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Vomiting	45.5% 5/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Diarrhea	45.5% 5/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Dry mouth	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Mucositis oral	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Constipation	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Dysphagia	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Anal hemorrhage	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Oral pain	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Anal pain	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Duodenal ulcer	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Flatulence	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Hemorrhoids	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Gastrointestinal disorders Salivary duct inflammation	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hyponatremia	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hypophosphatemia	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Anorexia	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hyperkalemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hypokalemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Dehydration	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hyperglycemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hypermagnesemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hypoalbuminemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Metabolism and nutrition disorders Hypomagnesemia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Injury, poisoning and procedural complications Fall	36.4% 4/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	30.8% 4/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Injury, poisoning and procedural complications Dermatitis radiation	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Injury, poisoning and procedural complications Burn	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Injury, poisoning and procedural complications Wound dehiscence	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	30.8% 4/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Bone pain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Neck Pain	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Blood and lymphatic system disorders Anemia	72.7% 8/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	46.2% 6/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Headache	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	38.5% 5/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Paresthesia	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	38.5% 5/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Dizziness	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Dysgeusia	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Stroke	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Amnesia	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Ataxia	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Dysarthria	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Hydrocephalus	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Hypoglossal nerve disorder	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Lethargy	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Memory impairment	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Nervous system disorders Presyncope	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Sore throat	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Postnasal drip	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Cough	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Hiccups	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Voice alteration	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Urinary tract infection	27.3% 3/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Sinusitis	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Infections and infestations - Other, specify	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Device related infection	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Meningitis	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Mucosal infection	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Sepsis	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Infections and infestations Wound infection	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Psychiatric disorders Insomnia	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	30.8% 4/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Psychiatric disorders Anxiety	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Psychiatric disorders Confusion	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Psychiatric disorders Depression	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Psychiatric disorders Psychiatric disorders - Other, specify	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Hematuria	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	23.1% 3/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Proteinuria	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Urinary incontinence	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Urinary retention	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Acute kidney injury	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Renal calculi	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Urinary tract obstruction	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Renal and urinary disorders Urinary urgency	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Skin and subcutaneous tissue disorders Rash acneiform	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Skin and subcutaneous tissue disorders Rash maculo-papular	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Skin and subcutaneous tissue disorders Erythema multiforme	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Endocrine disorders Hypothyroidism	18.2% 2/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Endocrine disorders Hyperthyroidism	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Vascular disorders Hypertension	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Vascular disorders Hot flashes	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Vascular disorders Hypotension	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Ear and labyrinth disorders Hearing impaired	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Ear and labyrinth disorders Vertigo	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Eye disorders Eye disorders - Other, specify	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Eye disorders Floaters	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	15.4% 2/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Cardiac disorders Atrial fibrillation	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Cardiac disorders Sinus tachycardia	0.00% 0/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	7.7% 1/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.
Reproductive system and breast disorders Vaginal hemorrhage	9.1% 1/11 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.	0.00% 0/13 • AEs and SAEs were to be reported within 30 days of last dose of administration, up to 219 weeks. For serious adverse events that occurred more than 30 days after the last administration of investigational agent/intervention, only reported those that had an attribution of at least possibly related to the agent/intervention.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: Bobby.Reddy@Immunitybio.com

Results disclosure agreements

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