Trial Outcomes & Findings for Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer (NCT NCT01711541)

NCT ID: NCT01711541

Last Updated: 2023-06-07

Results Overview

Dose Limiting Toxicity (DLTs) will be assessed during the first cycle of induction chemotherapy. The following events are considered DLTs: Grade 4 neutropenia (ANC \< 500) lasting more than 14 days, Febrile neutropenia, Grade 4 thrombocytopenia, dose delay of greater than 3 weeks due to failure to recover counts, treatment-related grade 3 or grade 4 non-hematological toxicity (excluding alopecia, fatigue, hypersensitivity reaction, nausea, vomiting, constipation, diarrhea, hypokalemia, hypomagnesemia, hypocalcemia, hypophosphatemia, and grade 3 hypertension), a dose delay of greater than 3 weeks for non-hematological toxicity despite replacement of electrolytes, maximum treatment for diarrhea, nausea, vomiting, and hypertension, any drug-related death. The number of patients reporting a DLT are reported below. The maximum tolerated dose (MTD) will be determined as the highest dose where 1 or fewer out of 6 patients reports a DLT.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: Up to 3 weeks
• Results posted on: 2023-06-07

Participant Flow

The study originally opened at Dose Level 0 with a treatment of Docetaxel, cisplatin and flouricil (TPF) in combination with ABT-888 (veliparib). With a concern for the feasibility of this regimen in other reported studies, this study was suspended and re-opened with a treatment of Carboplatin and Paclitaxel in combination with ABT-888.

Participant milestones

Measure	Dose Level 0 ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction	Dose Level 0B ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
Overall Study STARTED	4	4	3	6	7
Overall Study COMPLETED	4	3	3	5	7
Overall Study NOT COMPLETED	0	1	0	1	0

Reasons for withdrawal

Measure	Dose Level 0 ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction	Dose Level 0B ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
Overall Study Cancel prior to treatment	0	0	0	1	0
Overall Study Ineligible	0	1	0	0	0

Baseline Characteristics

Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer

Baseline characteristics by cohort

Measure	Dose Level 0 n=4 Participants ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction	Dose Level 0B n=4 Participants ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 n=3 Participants ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 n=6 Participants ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 n=7 Participants ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Total n=24 Participants Total of all reporting groups
Age, Continuous	72.5 years n=5 Participants	62.5 years n=7 Participants	67 years n=5 Participants	63.5 years n=4 Participants	61 years n=21 Participants	63.5 years n=10 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	14 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	23 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	20 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	6 participants n=4 Participants	7 participants n=21 Participants	24 participants n=10 Participants

PRIMARY outcome

Timeframe: Up to 3 weeks

Population: Dose Level 0 was not included in this outcome due to a change in treatment regimen. On Dose Level 0B, 1 patient was ineligible based on protocol criteria. On dose level 2, 1 patient cancelled prior to treatment, 1 had a dosing error and 1 pt did not complete cycle 1. On Dose Level 3, 1 patient cancelled prior to treatment.

Dose Limiting Toxicity (DLTs) will be assessed during the first cycle of induction chemotherapy.

The following events are considered DLTs: Grade 4 neutropenia (ANC < 500) lasting more than 14 days, Febrile neutropenia, Grade 4 thrombocytopenia, dose delay of greater than 3 weeks due to failure to recover counts, treatment-related grade 3 or grade 4 non-hematological toxicity (excluding alopecia, fatigue, hypersensitivity reaction, nausea, vomiting, constipation, diarrhea, hypokalemia, hypomagnesemia, hypocalcemia, hypophosphatemia, and grade 3 hypertension), a dose delay of greater than 3 weeks for non-hematological toxicity despite replacement of electrolytes, maximum treatment for diarrhea, nausea, vomiting, and hypertension, any drug-related death.

The number of patients reporting a DLT are reported below. The maximum tolerated dose (MTD) will be determined as the highest dose where 1 or fewer out of 6 patients reports a DLT.

Outcome measures

Measure	Dose Level 0 ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF induction.	Dose Level 0B n=3 Participants ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 n=3 Participants ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 n=3 Participants ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 n=6 Participants ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
Dose Limiting Toxicity (Phase I)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From baseline to 6 weeks

Population: The Phase II portion of this study never opened and no analysis was planned.

Treatment arms will be compared using the nonparametric Wilcoxon rank-sum test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upt to 5 years

Population: All patients that started protocol treatment and were evaluated for adverse events are included in this analysis. The Phase II portion of the study never opened, and therefore no data was collected.

Adverse Events were collected each cycle during treatment and follow-up according to the CTCAE v4.0 guidelines. The worst graded adverse event was determined for each patient. Below is a table of the number of patients that reported a Grade 3 or Grade 4 or Grade 5 as their worst reported event.

Outcome measures

Measure	Dose Level 0 n=4 Participants ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF induction.	Dose Level 0B n=3 Participants ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 n=3 Participants ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 n=5 Participants ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 n=7 Participants ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
Toxicity (Phase I and Phase II) Grade 3 Adverse Event	0 Participants	2 Participants	2 Participants	4 Participants	6 Participants
Toxicity (Phase I and Phase II) Grade 4 Adverse Event	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Toxicity (Phase I and Phase II) Grade 5 Adverse Event	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.

Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.

Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.

Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.

Summarized using cumulative incidence, and will be compared between groups using Gray's test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Population: No patients were eligible for this Phase II endpoint. The Phase II portion of this study never opened.

Summarized using the method of Kaplan-Meier, and compared between groups using the log-rank test. Multivariate Cox proportional hazards regression models will be used to further explore group differences adjusting for other prognostic factors, as well as to estimate hazard ratios.

Outcome measures

Outcome data not reported

Adverse Events

Dose Level 0

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 0B

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Level 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Dose Level 3

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 0 n=3 participants at risk ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction.	Dose Level 0B n=3 participants at risk ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 n=3 participants at risk ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 n=5 participants at risk ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 n=7 participants at risk ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
Cardiac disorders Myocardial infarction	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Esophagitis	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Mucositis oral	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Fever	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Malaise	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Skin infection	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations White blood cell decreased	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Acidosis	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hyperglycemia	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Respiratory failure	66.7% 2/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.

Other adverse events

Measure	Dose Level 0 n=3 participants at risk ABT-888 doses will be given at 200 mg bid for 7 days in combination with TPF Induction.	Dose Level 0B n=3 participants at risk ABT-888 doses will be given at 200 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 1 n=3 participants at risk ABT-888 doses will be given at 250 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 2 n=5 participants at risk ABT-888 doses will be given at 300 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.	Dose Level 3 n=7 participants at risk ABT-888 doses will be given at 350 mg bid for 7 days in combination with paclitaxel 100 mg/m2 and carboplatin AUC 6.
Blood and lymphatic system disorders Anemia	100.0% 3/3 • Number of events 18 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	80.0% 4/5 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 7/7 • Number of events 30 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Blood and lymphatic system disorders Febrile neutropenia	66.7% 2/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypernatremia	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Cardiac disorders Atrial flutter	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Ear and labyrinth disorders Hearing impaired	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Endocrine disorders Hyperthyroidism	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Endocrine disorders Hypothyroidism	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Diarrhea	100.0% 3/3 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Dry mouth	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	60.0% 3/5 • Number of events 9 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Dysphagia	100.0% 3/3 • Number of events 14 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 12 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Ileus	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Mucositis oral	100.0% 3/3 • Number of events 24 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 12 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 22 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 5/5 • Number of events 23 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 24 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 8 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	71.4% 5/7 • Number of events 9 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Oral hemorrhage	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Oral pain	66.7% 2/3 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	60.0% 3/5 • Number of events 12 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Chills	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Edema face	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Edema limbs	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Facial pain	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Fatigue	100.0% 3/3 • Number of events 19 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 13 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 16 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	60.0% 3/5 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 7/7 • Number of events 29 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Fever	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Gait disturbance	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Infusion related reaction	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Malaise	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 13 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
General disorders Pain	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Catheter related infection	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Mucosal infection	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Skin infection	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Upper respiratory infection	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Infections and infestations Urinary tract infection	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Injury, poisoning and procedural complications Dermatitis radiation	100.0% 3/3 • Number of events 15 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 14 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	60.0% 3/5 • Number of events 9 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Injury, poisoning and procedural complications Tracheostomy site bleeding	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Alanine aminotransferase increased	66.7% 2/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 5/5 • Number of events 21 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Alkaline phosphatase increased	100.0% 3/3 • Number of events 8 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 16 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Aspartate aminotransferase increased	100.0% 3/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 5/5 • Number of events 20 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Blood bilirubin increased	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	80.0% 4/5 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Creatinine increased	33.3% 1/3 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations INR increased	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Lipase increased	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Lymphocyte count decreased	100.0% 3/3 • Number of events 17 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	85.7% 6/7 • Number of events 23 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Lymphocyte count increased	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Neutrophil count decreased	100.0% 3/3 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	80.0% 4/5 • Number of events 8 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	85.7% 6/7 • Number of events 18 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Platelet count decreased	100.0% 3/3 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 11 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 14 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	80.0% 4/5 • Number of events 28 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 7/7 • Number of events 16 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Serum amylase increased	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations Weight loss	66.7% 2/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Investigations White blood cell decreased	66.7% 2/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	60.0% 3/5 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	85.7% 6/7 • Number of events 21 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 11 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	60.0% 3/5 • Number of events 12 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hyperglycemia	100.0% 3/3 • Number of events 13 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	71.4% 5/7 • Number of events 17 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 3/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypocalcemia	100.0% 3/3 • Number of events 9 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypoglycemia	66.7% 2/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypokalemia	100.0% 3/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 11 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hyponatremia	100.0% 3/3 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Hypophosphatemia	100.0% 3/3 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Neck pain	100.0% 3/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	42.9% 3/7 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Musculoskeletal and connective tissue disorders Trismus	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Aphonia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Dysarthria	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	100.0% 3/3 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Headache	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 11 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 12 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	40.0% 2/5 • Number of events 10 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 15 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Nervous system disorders Syncope	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Psychiatric disorders Confusion	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Psychiatric disorders Delirium	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Psychiatric disorders Depression	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Renal and urinary disorders Chronic kidney disease	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 8 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Laryngeal hemorrhage	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Sore throat	100.0% 3/3 • Number of events 6 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	57.1% 4/7 • Number of events 7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Respiratory, thoracic and mediastinal disorders Voice alteration	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	66.7% 2/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	20.0% 1/5 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	28.6% 2/7 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Rash maculo-papular	66.7% 2/3 • Number of events 4 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	33.3% 1/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Vascular disorders Flushing	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	14.3% 1/7 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Vascular disorders Hot flashes	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	33.3% 1/3 • Number of events 3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.
Vascular disorders Hypotension	66.7% 2/3 • Number of events 2 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/3 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/5 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.	0.00% 0/7 • Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. Adverse events were collected every week during treatment (up to 13 weeks) and then every 6 months during clinical follow-up for a maximum of 5 years from registration. All patients that began study treatment and were assessed for adverse events are included in this analysis. Patients that cancelled or were not evaluated for adverse events were not included.

Additional Information

Everett E. Vokes, M.D.

Alliance for Clinical Trials in Oncology

Phone: 773-702-9306

Email: evokes@medicine.bsd.uchicago.edu

Results disclosure agreements

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

Restriction type: LTE60