Trial Outcomes & Findings for Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC) (NCT NCT00313781)

Last Updated: 2013-04-11

Results Overview

Percentage of participants with PSA best response of either PSA normalization (PN) or partial PSA response (PR) relative to the total number of participants evaluable for response. PN was defined as PSA =\< 0.2 nanogram/milliliter (ng/ml) on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression. PP was defined as \>= 50% decrease in PSA from baseline on 2 successive evaluations at least 3 weeks apart and no imaging or clinical evidence of disease progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

204 participants

Primary outcome timeframe

Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

Results posted on

2013-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	CP-751,871+Docetaxel+Prednisone Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Before Crossover STARTED	102	102	0
Before Crossover Treated	97	102	0
Before Crossover COMPLETED	27	23	0
Before Crossover NOT COMPLETED	75	79	0
After Crossover STARTED	0	0	37
After Crossover COMPLETED	0	0	10
After Crossover NOT COMPLETED	0	0	27

Reasons for withdrawal

Reasons for withdrawal
Measure	CP-751,871+Docetaxel+Prednisone Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Before Crossover Death	22	8	0
Before Crossover Lost to Follow-up	0	3	0
Before Crossover Withdrawal by Subject	3	1	0
Before Crossover Other	45	30	0
Before Crossover Crossover	0	37	0
Before Crossover Randomized, not treated	5	0	0
After Crossover Death	0	0	6
After Crossover Withdrawal by Subject	0	0	3
After Crossover Other	0	0	18

Baseline Characteristics

Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CP-751,871+Docetaxel+Prednisone n=102 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=102 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Total n=204 Participants Total of all reporting groups
Age, Customized Less than (<) 18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18 to 44 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Customized 45 to 64 years	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Age, Customized Greater than or equal to (>=) 65 years	76 Participants n=5 Participants	69 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	102 Participants n=7 Participants	204 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose)

Population: Response-evaluable population: All enrolled participants who had a baseline PSA reference value and received at least one dose of assigned treatment with the exception of those participants without symptomatic or objective progression (participants with PSA progression only) who withdraw consent prior to Cycle 3.

Outcome measures

Outcome measures
Measure	CP-751,871+Docetaxel+Prednisone n=87 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=98 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover n=32 Participants Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Percentage of Participants With Prostate Specific Antigen (PSA) Best Response	51.7 Percentage of participants Interval 42.4 to 61.0	60.2 Percentage of participants Interval 51.4 to 68.5	28.1 Percentage of participants Interval 15.5 to 43.9

SECONDARY outcome

Timeframe: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose)

Population: Full analysis set included all participants who were enrolled into the study and received at least one assigned treatment.

PFS was defined as the time from randomization to first event of disease progression. Disease progression events were defined as the following: PSA progression,objective disease progression as per RECIST, death, and discontinuation of treatment due to symptomatic deterioration. PSA progression was defined as the time-point of PSA progression on 2 successive evaluations taken 1 week apart after dosing in cycle 3.

Outcome measures

Outcome measures
Measure	CP-751,871+Docetaxel+Prednisone n=97 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=102 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover n=37 Participants Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Progression Free Survival (PFS)	4.9 Months Interval 4.1 to 5.9	7.7 Months Interval 6.1 to 8.9	4.0 Months Interval 3.3 to 4.8

SECONDARY outcome

Timeframe: Baseline (Day 1 of Cycle 1)

Population: All participants who were enrolled in the study, received at least one assigned treatment and had available HAHA assessment.

Levels of HAHA in serum were detected at baseline.

Outcome measures

Outcome measures
Measure	CP-751,871+Docetaxel+Prednisone n=49 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=41 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1)	1130.3 mg/deciliter (dl) Standard Deviation 406.49	1338.1 mg/deciliter (dl) Standard Deviation 804.30	—

SECONDARY outcome

Timeframe: The last follow-up visit (150 days post last dose)

Population: All participants who were enrolled in the study, received at least one assigned treatment and had HAHA available assessment.

Levels of HAHA in serum were detected at the last follow-up visit.

Outcome measures

Outcome measures
Measure	CP-751,871+Docetaxel+Prednisone n=32 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=13 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover n=14 Participants Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Human Anti-human Antibody (HAHA) at the Last Follow-up Visit	944.81 mg/dl Standard Deviation 946.42	819.00 mg/dl Standard Deviation 487.94	970.86 mg/dl Standard Deviation 295.28

SECONDARY outcome

Timeframe: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for CP-751,871 and to determine inter-individual and residual variability in population clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured CP-751,871 concentrations

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

Population: Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.

Blood samples were collected and processed to enumerate the number of total CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive epithelial cell adhesion molecule (EpCAM) and cytokeratin staining.

Outcome measures

Outcome measures
Measure	CP-751,871+Docetaxel+Prednisone n=46 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=39 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Total Number of Circulation Tumor Cells (CTCs) Baseline (Cycle 1 Day 1) (n=46, 39)	105.17 Number of CTCs/7.5 mL Standard Deviation 259.60	213.23 Number of CTCs/7.5 mL Standard Deviation 555.82	—
Total Number of Circulation Tumor Cells (CTCs) Cycle 3 Day1 (n=28, 29)	6.39 Number of CTCs/7.5 mL Standard Deviation 11.39	12.21 Number of CTCs/7.5 mL Standard Deviation 27.52	—
Total Number of Circulation Tumor Cells (CTCs) Cycle 5 Day 1 (n=25, 23)	15.20 Number of CTCs/7.5 mL Standard Deviation 46.40	17.78 Number of CTCs/7.5 mL Standard Deviation 28.11	—

SECONDARY outcome

Timeframe: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose)

Population: Participants who were enrolled to the study were included in the analysis. n = number of participants with evaluable data at each timeframe.

Blood samples were collected to enumerate the number of total IGF-1R positive CTCs via Veridex CellSearch technology in which CTCs were identified based on cell surface positive EpCAM and cytokeratin staining. A separate CellSave tube of cells was also collected and processed with cell surface staining of IGF-1R to enumerate surfaces of IGF-1R-positive CTCs.

Outcome measures

Outcome measures
Measure	CP-751,871+Docetaxel+Prednisone n=22 Participants Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=18 Participants Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs Baseline (Cycle 1 Day 1) (n=22, 18)	24.73 Number of IGF-1R positive CTCs/7.5 mL Standard Deviation 25.32	54.94 Number of IGF-1R positive CTCs/7.5 mL Standard Deviation 55.52	—
Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs Cycle 3 Day1 (n=12, 15)	2.33 Number of IGF-1R positive CTCs/7.5 mL Standard Deviation 4.48	4.93 Number of IGF-1R positive CTCs/7.5 mL Standard Deviation 7.74	—
Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs Cycle 5 Day 1 (n=11, 10)	2.00 Number of IGF-1R positive CTCs/7.5 mL Standard Deviation 4.49	3.90 Number of IGF-1R positive CTCs/7.5 mL Standard Deviation 6.03	—

SECONDARY outcome

Timeframe: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

Population: The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the patient reported outcome (PRO) summary irrelevant 2) lack of resources as the program was terminated.

The FACT-P was a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The total FACT-P score ranged from 0-156, with higher scores representing a better QoL with fewer symptoms. A score of 156 represented the best outcome.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose)

Population: The summary table was not provided based on 1) the negative primary finding of the study that CP-751,871 did not improve response in CP-751,871+Docetaxel + Prednisone and had significantly worse PFS than Docetaxel +Prednisone, which rendered the PRO summary irrelevant 2) lack of resources as the program was terminated.

The mBPI-sf was a self administered questionnaire developed to assess pain severity and pain interference with functional activities during a 24-hour period prior to evaluation. For the worst pain item of the mBPI-sf scale (11 point Likert scale; range: 0 \[no pain\] to 10 \[pain as bad as you can imagine\]), participants were asked to rate their pain by marking an "X" in one of the 10 boxes that best described their pain at its worst in the last 24 hours post surgery and at least 12 hours after discontinuation of the peripheral nerve block or neuraxial block.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose)

Population: The summary table of this outcome measure was not provided based on lack of resources as the program was terminated.

Outcome measures

Outcome data not reported

Adverse Events

CP-751,871+Docetaxel+Prednisone

Serious events: 64 serious events

Other events: 96 other events

Deaths: 0 deaths

Docetaxel+Prednisone

Serious events: 37 serious events

Other events: 53 other events

Deaths: 0 deaths

Docetaxel+Prednisone+CP-751,871 Crossover

Serious events: 20 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	CP-751,871+Docetaxel+Prednisone n=97 participants at risk Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=102 participants at risk Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover n=37 participants at risk Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Blood and lymphatic system disorders Anaemia	2.1% 2/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Febrile neutropenia	12.4% 12/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	6.9% 7/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Leukopenia	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Neutropenia	10.3% 10/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Thrombocytopenia	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Acute coronary syndrome	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Acute myocardial infarction	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Atrial fibrillation	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Cardiac failure	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Cardiogenic shock	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Cardiopulmonary failure	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Myocardial infarction	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Cardiac disorders Myocardial ischaemia	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Endocrine disorders Hypercalcaemia of malignancy	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Eye disorders Vitreous haemorrhage	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Abdominal pain	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Anal fissure	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Colitis ischaemic	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Diarrhoea	9.3% 9/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Dysphagia	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Faecaloma	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Intestinal perforation	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Nausea	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Rectal haemorrhage	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Stomatitis	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Gastrointestinal disorders Vomiting	4.1% 4/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Asthenia	4.1% 4/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Chest pain	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Death	2.1% 2/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Disease progression	8.2% 8/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.9% 3/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	16.2% 6/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Drug interaction	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Fatigue	5.2% 5/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	8.1% 3/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
General disorders Pyrexia	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Immune system disorders Hypersensitivity	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Infections and infestations Abscess	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Infections and infestations Candidiasis	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Infections and infestations Cellulitis	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Infections and infestations Clostridial infection	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Infections and infestations Diverticulitis	4.1% 4/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.

Other adverse events
Measure	CP-751,871+Docetaxel+Prednisone n=97 participants at risk Participants received docetaxel 75 milligram(mg)/square meter(m\^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.	Docetaxel+Prednisone n=102 participants at risk Participants received docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.	Docetaxel+Prednisone+CP-751,871 Crossover n=37 participants at risk Participants from the "Docetaxel+Prednisone" group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m\^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
Skin and subcutaneous tissue disorders Dermatitis allergic	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Dry skin	9.3% 9/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	13.7% 14/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	10.8% 4/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Investigations Blood creatinine increased	9.3% 9/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.1% 2/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Rales	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.2% 8/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	4.9% 5/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Tachypnoea	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Acne	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Alopecia	47.4% 46/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	50.0% 51/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	45.9% 17/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Blood blister	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Dermatitis	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Ecchymosis	5.2% 5/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Erythema	8.2% 8/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	9.8% 10/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Hair disorder	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.9% 3/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	5.4% 2/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Hyperkeratosis	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Hypoaesthesia facial	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Intertrigo	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Macule	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Nail bed bleeding	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Nail bed disorder	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Nail discolouration	2.1% 2/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.0% 2/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Skin and subcutaneous tissue disorders Nail discomfort	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Anaemia	13.4% 13/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	20.6% 21/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	29.7% 11/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Febrile neutropenia	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Hypochromic anaemia	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Leukopenia	22.7% 22/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	23.5% 24/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	10.8% 4/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Lymphadenitis	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Lymphadenopathy	1.0% 1/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Lymphopenia	8.2% 8/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	9.8% 10/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	10.8% 4/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Neutropenia	35.1% 34/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	36.3% 37/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	27.0% 10/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.00% 0/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.00% 0/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.
Blood and lymphatic system disorders Thrombocytopenia	5.2% 5/97 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	0.98% 1/102 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.	2.7% 1/37 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. 199 out of 204 participants were treated.